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NDC 72785-0011-06 cisatracurium besylate 2 mg/mL Details
cisatracurium besylate 2 mg/mL
cisatracurium besylate is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is CISATRACURIUM BESYLATE.
Product Information
NDC | 72785-0011 |
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Product ID | 72785-0011_edbc4b0d-92ea-48b7-a7d7-406c82d40221 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | cisatracurium besylate |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | cisatracurium besylate |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION |
Route | INTRAVENOUS |
Active Ingredient Strength | 2 |
Active Ingredient Units | mg/mL |
Substance Name | CISATRACURIUM BESYLATE |
Labeler Name | Zydus Lifesciences Limited |
Pharmaceutical Class | Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA213527 |
Listing Certified Through | 2024-12-31 |
Package
Package Images



NDC 72785-0011-06 (72785001106)
NDC Package Code | 72785-0011-6 |
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Billing NDC | 72785001106 |
Package | 10 VIAL in 1 CARTON (72785-0011-6) / 10 mL in 1 VIAL (72785-0011-1) |
Marketing Start Date | 2020-11-05 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ac58faa8-7291-4128-9646-c00be0ce3f81 Details
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 72758-0011-1
Cisatracurium Besylate Injection, USP
20 mg/10 mL*
(2 mg/mL)
WARNING: Paralyzing Agent
For Intravenous Injection
0.9% benzyl alcohol (added as a preservative)
10 mL Multiple-Dose Vial
Rx only

NDC 72758-0011-1
Cisatracurium Besylate Injection, USP
20 mg/10 mL*
(2 mg/mL)
WARNING: Paralyzing Agent
For Intravenous Injection
0.9% benzyl alcohol (added as a preservative)
10 mL Multiple-Dose Vial
Rx only

NDC 72758-0011-6
Cisatracurium Besylate Injection, USP
20 mg/10 mL*
(2 mg/mL)
WARNING: Paralyzing Agent
For Intravenous Injection
0.9% benzyl alcohol (added as a preservative)
10 x 10 mL Multiple-Dose Vial
Rx only

INGREDIENTS AND APPEARANCE
CISATRACURIUM BESYLATE
cisatracurium besylate injection |
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Labeler - Zydus Lifesciences Limited (873671928) |
Registrant - Zydus Lifesciences Limited (873671928) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Zydus Lifesciences Limited | 873671928 | MANUFACTURE(72785-0011) , ANALYSIS(72785-0011) |